Guidelines for PrEP in PWID

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1 Guidelines for PrEP in PWID Any use of injection drugs (past 6 months) AND Any sharing of injection equipment OR participation in methadone, naloxone, or buprenorphine treatment program (past 6 months) OR risk of sexual acquisition Additional consideration: transactional sex and high community and/or sexual network HIV prevalence USPHS/CDC. CDC. 1

2 Eligibility Screening for PrEP Before PrEP is initiated: HIV HIV negative a Renal function CrCl 60 ml/min HBV TDF is an approved treatment for HBV, but TDF/FTC is not a Refer patients to provider experienced in HBV treatment Pregnancy Positive pregnancy test result does not preclude women from PrEP, but potential risks and benefits of PrEP should be discussed a Boxed warning. USPHS/CDC. On-Treatment Monitoring At Least Every 3 Months At Least Every 6 Months At Least Every 12 Months Repeat HIV test Monitor ecrcl Evaluate the need to Repeat pregnancy test continue PrEP as part of (for women) HIV prevention Authorize PrEP refill for no more than 90 days Assess side effects, a,b adherence, HIV acquisition risk Provide support for adherence and risk-reduction behavior Perform recommended STI testing for sexually active adults (eg, syphilis, gonorrhea, chlamydia) a The most common side effects associated with PrEP medication are nausea, cramping, and weight loss. These symptoms are mild and usually temporary. Losses in BMD associated with TDF/FTC as PrEP use are recovered after stopping TDF/FTC. b Boxed warning: Lactic acidosis and severe hepatomegaly with steatosis have been reported with the use of nucleoside inhibitors, including TDF. USPHS/CDC. Truvada [package insert]. Foster City, CA: Gilead Sciences, Inc.;

3 Clinical Study of PrEP in PWID Bangkok Tenofovir Study (2013) investigated the effects of a PrEP strategy for HIV prevention in 2,413 Thai PWID Cumulative Probability of HIV Infection, % Kaplan-Meier Estimates of Time to HIV Infection in the Modified Intention-to-Treat Population TDF Placebo Number at Risk Months Since Randomization TDF 1,204 1, Placebo 1,207 1, % reduction in HIV incidence (95% CI, ; P =.01) 73.5% reduction in HIV incidence in individuals with detectable drug levels (95% CI, ; P =.03) Choopanya K, et al. Lancet. 2013;381: PrEP Efficacy Across Subpopulations Efficacy 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Partners PrEP (TDF/FTC) Partners PrEP (TDF) TDF2 (TDF/FTC) iprex (TDF/FTC) Bangkok Tenofovir Study (TDF) Overall Detectable TDF Overall 75.0% 67.0% 62.2% 44.0% 48.9% Detectable TDF 90.0% 86.0% 77.9% 92.0% 73.5% P Value.002 < < Baeten JM, et al. N Engl J Med. 2012;367: ; Thigpen MC, et al. N Engl J Med. 2012;367:423-34; Grant RM, et al. N Engl J Med. 2010;363: ; Choopanya K, et al. Lancet. 2013;381:

4 WWID and HIV Transmission WWID have higher odds (OR, 1.18) of HIV infection than MWID (95% CI, ) WWID are more likely to have higher risk of sexual and injection exposures than MWID Concomitant or overlapping exposures WWID who are unable to negotiate safe sex practices are especially at risk of HIV transmission and could benefit greatly from PrEP for HIV prevention Des Jarlais DC, et al. Drug Alcohol Depend. 2012;124:95-107; Coleman RL, et al. J Int AIDS Soc. 2016;19: PCP Willingness to Provide PrEP to PWID PCPs more likely to report willingness to provide PrEP to every other risk group (P <.03 for all comparisons) Number of patients with HIV under PCP care significantly associated with PCP willingness to provide PrEP to PWID PCPs caring for 20 or fewer patients with HIV more likely to report low willingness (OR, 6.38; 95% CI, ) Person who has been on methadone maintenance for the past 6 months but has continued injection drug use Person who has injected drugs in the past 6 months and shared injection equipment Female who has unprotected sex with male partners with unknown HIV status who are at high risk of HIV infection Male with a current female partner known to be HIV positive Male who has sex with multiple male partners and has unprotected anal sex Male who has unprotected sex with male partners with unknown HIV status who are at high risk of HIV infection Male with a current male partner known to be HIV positive Female with a current male partner known to be HIV positive Low Willingness High Willingness 35% 65% 26% 74% 16% 84% 14% 86% 12% 88% 11% 89% 9% 91% 9% 91% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Edelman EJ, et al. AIDS Behav [Epub ahead of print]. 4

5 Acknowledgment of Commercial Support This activity is supported by an educational grant from Gilead Sciences, Inc. Contact Information Call (toll-free) Please visit us online at for additional activities provided by Med-IQ. To receive credit, click the Get Credit tab at the bottom of the Webcast for access to the evaluation, attestation, and post-test Unless otherwise indicated, photographed subjects who appear within the content of this activity or on artwork associated with this activity are models; they are not actual patients or doctors. 5

6 Abbreviations/Acronyms BMD = bone mineral density CDC = Centers for Disease Control and Prevention CrCl = creatinine clearance ecrcl = estimated creatinine clearance FTC = emtricitabine HBV = hepatitis B virus HIV = human immunodeficiency virus MWID = men who inject drugs PCP = primary care provider PHS = Public Health Service PrEP = pre exposure prophylaxis PWID = persons who inject drugs STI = sexually transmitted infection TDF = tenofovir disoproxil fumarate WWID = women who inject drugs

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